NRx Reports 34% Remission Rate for IV Ketamine Versus 26% Esketamine
NRXP•NRx showcased data showing IV ketamine achieved 34% remission and 63% response in 8,224 patients versus 26% remission and 58% response in 1,830 intranasal esketamine cases (ORs 1.51 and 1.22; P<.001, P<.003). The matched-cohort analysis underscores superior efficacy and bolsters regulatory reliance on real-world evidence.
1. Conference Presentation
NRx Pharmaceuticals presented a peer-reviewed poster at the American Society of Clinical Psychopharmacology conference, showcasing a retrospective comparative study on IV ketamine versus intranasal esketamine. The poster, co-authored by Osmind researchers and a Yale University psychiatry professor, highlights NRx’s engagement in real-world evidence initiatives.
2. Study Design and Cohort Matching
Researchers analyzed de-identified electronic health records from 800 community psychiatry clinics, identifying 8,224 patients treated with IV ketamine and 1,830 with intranasal esketamine. A matched analysis set of 3,560 patients ensured balanced baseline characteristics for valid comparator cohorts.
3. Efficacy Findings and Statistics
IV ketamine recipients achieved 34% remission and 63% response, versus 26% remission and 58% response for intranasal esketamine (OR 1.51 for remission; OR 1.22 for response; P<.001, P<.003). These outcomes indicate significantly higher real-world efficacy for IV ketamine in treatment-resistant depression.
4. Limitations and Regulatory Implications
The primary limitation is the non-randomized treatment assignment, which may permit unmeasured confounders to influence results. The study’s reliance on real-world evidence aligns with recent federal directives and informs NRx’s regulatory strategy for NRX-100 ahead of larger confirmatory trials and FDA review.
